The present invention relates to a suspension device for surgically treating prolapse, in particular genital, urinary and rectal prolapse, and urinary incontinence in elderly women.
Genital, urinary and rectal prolapses result from a slackening of the tissues supporting the organs, and of the perineum. Their surgical treatment involves connecting one or more of these organs (bladder, vagina, uterus, rectum) to anatomically stable zones, in particular, anteriorly, at Cooper""s ligament, on the postero-superior margin of the pubis or, posteriorly, at the area of the promontory, that is to say the antero-superior angle of the sacrum, by xe2x80x9csuspendingxe2x80x9d these organs on these anatomically stable zones.
Surgical treatment of prolapses is presently carried out using nonabsorbable sutures or strips for strengthening of walls.
Sutures have the advantage of being easy to put in place during treatment of a prolapse by open surgery, of having a low cost and of having extensive possibilities of use.
However, they have the disadvantage of providing a punctiform and somewhat inelastic fixation of the suspension filament, which is likely to cause shearing of the tissues on which they are placed, leading to rupturing of the anchoring arrangement. The result of this is that their efficacy is limited in time. Moreover, they are complicated to put into place when treating prolapses by laparoscopy, given the need to form numerous knots.
Strips have the advantage of being easy to put into place irrespective of the route employed (open surgery or laparoscopy), of being effective, and of allowing the stresses which are exerted to be distributed at a plurality of anchoring points. They are also capable of rapid incorporation in the anchoring wall by means of tissue growth.
However, these strips have the disadvantage of having to be twisted when the respective implantation walls are not parallel. The twisted zone acts in scarcely favorable conditions, moving along the band when tension is applied, with the latter becoming thinner at its center, making it difficult to put into place and accentuating the shearing effect. A band of relatively rigid material, such as monofilament polypropylene, has edges which could damage the surrounding tissues along the entire length of the band.
There is at present no available implant which is entirely satisfactory for specific treatment of prolapse and urinary incontinence, and the present invention aims to remedy this deficit.
To this end, the device to which the invention relates comprises at least one filiform suspension cord, made of nonabsorbable material and with limited elasticity, and at least two anchoring parts connected to the ends of this cord; these anchoring parts are made of sheet material, having a flexible and openworked structure, capable of adapting to the configuration of the respective implantation walls, and said parts are intended to be fixed to these same walls by appropriate means, such as suturing or stapling, and then to be incorporated in these walls by regrowth of tissue through them.
Thus, unlike the means employed in the prior art, the device according to the invention has a dual structure, each component (cord or anchoring parts) being optimized for the function which it is intended to fulfill: the cord, because it is filiform, does not damage the surrounding tissues, and any twisting thereof is without any consequence on its pulling action and hence on its strength over the course of time, or on the maneuverability of the device; by virtue of the elasticity of this cord, the surgeon can adapt the tension of the suspension without disturbing the anchoring zones; the anchoring parts can be adapted to the shape of their anchoring site and can be fixed thereto at a plurality of mutually remote points and then be incorporated in the walls on which they are anchored by regrowth of tissue through them.
The ruptures of the sutures as a result of shearing at the anchoring points are eliminated and the openworked structure of the anchoring parts permits early and intimate tissue incorporation, without formation of a peripheral fibrous shell, for the purpose of a functional recovery and a rapid convalescence of the patient.
According to one embodiment of the invention, the device comprises a cord and two anchoring parts, one of which is fixed to one of the ends of the cord, and the other of which is fixed to the other of these ends.
One of the anchoring parts is intended to be fixed to the organ to be suspended, and the other to the anatomically stable zone. This device can be used in particular, singly or doubly, to permit a posterior uterine or rectal suspension with anchoring in the area of the promontory, or a cystopexy by suspension of the anterior and lateral walls of the vagina on Cooper""s ligament (called the Burch technique).
According to another embodiment of the invention, the device comprises a cord, two anchoring parts fixed to each of the ends of the cord, and an anchoring part fixed at a defined site along the length of the cord, in particular in the median zone thereof.
The anchoring parts fixed to the ends of the cord are connected to the anatomically stable zone, while the anchoring part fixed at a defined site along the length of the cord surrounds part of the organ to be suspended, in the manner of a sling. The device configured in this way can be used in particular for cystopexy with a subcervical sling.
According to yet another embodiment of the invention, the device comprises two cords which are each equipped with an anchoring part connected to one of their ends, the two other ends of these cords being connected to a single anchoring part.
The anchoring parts connected to one of the ends of the cords are intended to be fixed to the anatomically stable zone, while said single anchoring part is intended to be fixed to the organ to be suspended. This device can be used in particular to permit vaginal suspension on the promontory in cases where the uterus is not removed.
The cords can be parallel or form an angle with each other.
According to yet another embodiment of the invention, the device comprises two cords which are each equipped with an anchoring part connected to one of their ends, the two other ends of the cords being connected to two anchoring parts, which are themselves connected to one another in the area of one of their edges.
These two anchoring parts when assembled thus have a leaf shape allowing the whole arrangement to be engaged either side of part of an organ, in particular on the end of this organ, which it can xe2x80x9ccapxe2x80x9d. The device configured in this way can be used in particular for suspension of the vagina on the promontory after hysterectomy.
The cord is preferably made of a braid of yarns of polypropylene or polyethylene terephthalate (polyester).
The elasticity curve of this cord is as linear as possible so as to allow the operating surgeon to adjust the tension. A tensile strength of ten kilos is easily sufficient, and an elongation at break of the order of 40% obtained linearly from a load of one or two kilos is preferable.
The cord is preferably made of a warp-knitted braid formed by four two-ended yarns of textured 167 decitex polyester.
This cord advantageously has a cross section greater than about one square millimeter in order to avoid any cutting action on the surrounding tissues during tensioning.
The anchoring parts can be made of a knitted or nonwoven lattice, preferably of polypropylene or polyethylene terphthalate (polyester), of the type used for strengthening walls after treatment of inguinal hernias. They have shapes and dimensions adapted to the anchoring to be performed and they are preferably of a very openworked structure to permit the aforementioned regrowth of tissue through them.
The material of the cord and of the anchoring parts is preferably identical.
The cord and the anchoring parts can be joined by stitching or welding, in particular by ultrasound.